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Antibody manufacturing and analytical testing points
Regulatory guidelines require manufacturers to establish a quality system and to follow Good Manufacturing Practices (GMP) to ensure that the therapeutic antibody is produced in a controlled and consistent manner.
Using molecular methods for analytical testing in bioprocessing offers substantial benefits, significantly enhancing both efficiency and accuracy in the production process. Advanced techniques such as qPCR, dPCR, and next-generation sequencing provide exceptional sensitivity and specificity, enabling the detection of low-abundance contaminants and ensuring product purity. These methods facilitate rapid and precise detection, quantitation or identification, of contaminants and impurities, allowing for quality control of bioprocesses. In addition, these methods help contribute to improved product consistency and compliance with stringent regulatory standards, enabling quality biopharmaceuticals and reduced production costs.
Benefits of the Applied Biosystems SEQ solutions
- Analyze your product throughout the development process to help ensure product quality and safety
- Leverage a fully integrated solution, including assay kits, instruments, and analysis software designed to save time, help free up development resources, and enable more consistent results to help therapies get released quickly
- Develop rigorous host cell DNA clearance studies during development and validation through magnetic bead-based sample preparation and automation options
- Help quickly determine if impurity level—such as residual host cell DNA—meets quality and regulatory requirements
- Utilize rapid molecular methods (real-time PCR, digital PCR, and DNA sequencing), enabling high sensitivity, fast results, and increased throughput—including the option to deploy an automated process for various tests
Antibody production workflow testing points
While specific requirements can vary depending on the regulatory jurisdiction and the nature of the therapeutic antibody*, common tests consist of:
- Product safety : Includes assessments for sterility and viral contamination
- Product quality : Screening for impurities such as residual host cell DNA
- Environmental monitoring : Microbial contamination detection and identification within the manufacturing environment
*Regulatory agencies may require additional data or specific assays tailored to the unique attributes of therapeutic antibodies to ensure their safety, efficacy, and quality.
* Currently recommended for in-process / raw material testing.
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